Cleared Traditional

K841374 - HOME PRO VOLUMETRIC INFUSION PUMP

K841374 is an FDA 510(k) clearance for HOME PRO VOLUMETRIC INFUSION PUMP, manufactured by American Edwards Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K841374 · American Edwards Laboratories · General Hospital
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Feb 1985
Decision
318d
Days
Class 2
Risk

K841374 is an FDA 510(k) clearance for the HOME PRO VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

FDA 510(k) Submission Details - K841374

510(k) Number K841374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date February 15, 1985
Days to Decision 318 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 129d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841374.
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · Pharmacia, Inc. · Apr 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K850488 · Strato Medical Corp. · Mar 1985
IMED 980 VOLUMETRIC INFUSION PUMP
K844915 · Imed Corp. · Mar 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · Strato Medical Corp. · Jan 1985
360 INFUSER
K844719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K844730 · C.R. Bard, Inc. · Jan 1985